IMM01+Azacitidine VS Placebo +Azacitidine in Patients With Newly Diagnosed Chronic Myelomonocytic Leukemia (CMML1-2)
NCT ID: NCT06647862
Last Updated: 2025-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
170 participants
INTERVENTIONAL
2024-11-11
2029-10-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IMM01 in combination with azacitidine
One treatment cycle consists of 4 weeks (28 days). IMM01(timdarpacept) will be administered once weekly, and azacitidine will be administered from Day 1 to Day 7 of each cycle.
IMM01
IV infusion
Azacitidine
subcutaneous injection
placebo in combination with azacitidine
One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and azacitidine will be administered on days 1-7 of each cycle.
Azacitidine
subcutaneous injection
Placebo
IV infusion
Interventions
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IMM01
IV infusion
Azacitidine
subcutaneous injection
Placebo
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
* Life expectancy ≥ 12 weeks;
* Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2;
* White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed).
* Patients must be treatment-naïve to any systemic agents for CMML (e.g., azacitidine, decitabine,chemotherapy\<1 cycle, and the washout period should be more than 28 days, which is acceptable.), allogeneic stem cell transplant for CMML. Note: During screening and study participation, subjects may continue oral corticosteroids for diseases other than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. In addition, supportive care in the form of blood transfusions or growth factors is not considered prior therapy in this case and is permitted prior to and as needed during the study.
Exclusion Criteria
* History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant;
* Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome / Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN including atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded;
* Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma;
* Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin cancer,Surgery-cured prostate cancer and papillary thyroid cancer; b. a second primary cancer that has been curatively treated and has no recurrence within three years;
18 Years
ALL
No
Sponsors
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
OTHER
Responsible Party
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Principal Investigators
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zhijian xiao, PHD
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Hongyan Tong, PHD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
China-Japan Friendship Hospita
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Gaungxi, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
Zhujiang Hospital of Southern Medical University
Zhujiang, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Hebei University
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin First Hospital
Harbin, Heilongjiang, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
Zhengzhou, Henan, China
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Changzhou First People's Hospital
Changzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Zhongda Hospital affiliated to Southeast University
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangsu Subei People's Hospital
Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shaanxi Provincial People's Hospital
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo First Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Peking University People's Hospital
Beijing, , China
Tianjin People's Hospital
Tianjin, , China
Countries
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Central Contacts
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Facility Contacts
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weiming Li
Role: primary
fuling Zhou
Role: primary
guolin yuan
Role: primary
yajing xu
Role: primary
zunmin Zhu
Role: primary
haiping Yang
Role: primary
xiaoyu zhu
Role: primary
zhenling li
Role: primary
li wang
Role: primary
bei liu
Role: primary
zhenfang liu
Role: primary
dan xu
Role: primary
xin du
Role: primary
chaoyang Song
Role: primary
xin Du
Role: primary
jishi wang
Role: primary
hua xue
Role: primary
jinhai Ren
Role: primary
tiejun Gong
Role: primary
lijie Han
Role: primary
hu Zhou
Role: primary
zhiping jiang
Role: backup
weiying gu
Role: primary
wenyi shen
Role: primary
zheng Ge
Role: primary
miao miao
Role: primary
zhenyu li
Role: primary
mei sun
Role: primary
fei Li
Role: primary
hai Lin
Role: primary
wei Yang
Role: primary
xiaojing Yan
Role: primary
qiang song
Role: primary
yi wang
Role: primary
xiaobing huang
Role: primary
shihua huang
Role: primary
jianping hao
Role: primary
zeping Zhou
Role: primary
guifang ouyang
Role: primary
songfu jiang
Role: primary
qian Jiang
Role: primary
xingli Zhao
Role: primary
Other Identifiers
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IMM01-010
Identifier Type: -
Identifier Source: org_study_id
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